A Study of the Immunogenicity and Safety of the 2007-2008 Influenza Vaccine

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00491257

Collaborator

(none)

130

Enrollment

Locations

Arms

Duration (Days)

Patients Per Site

65.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.

The objectives of the trial are:

To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008 formulation.

Condition or Disease	Intervention/Treatment	Phase
Influenza Orthomyxoviridae Infections	Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Group 1 Participants aged 18 to 60 years at enrollment	Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation 0.5 mL, Intramuscular Other Names: Vaxigrip
Experimental: Study Group 2 Participants aged 61 years or older at enrollment.	Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation 0.5 mL, Intramuscular Other Names: Vaxigrip

Arm

Intervention/Treatment

Experimental: Study Group 1

Participants aged 18 to 60 years at enrollment

Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation

0.5 mL, Intramuscular

Other Names:

Vaxigrip

Experimental: Study Group 2

Participants aged 61 years or older at enrollment.

Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation

0.5 mL, Intramuscular

Other Names:

Vaxigrip

Outcome Measures

Primary Outcome Measures

To provide information concerning the immunogenicity of 2007-2008 Influenza vaccine (split virion, inactivated). [21 Days post-vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria :

Aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or above (from the day of the 61st birthday) on the day of inclusion
Provision of a signed informed consent
Able to attend all scheduled visits and comply with all trial procedures
For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination

Exclusion Criteria :

For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
Febrile illness (temperature >= 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
Breast-feeding woman
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
Known systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Planned receipt of any vaccine in the 3 weeks following the trial vaccination
Previous vaccination against influenza in the previous 6 months
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or Hepatitis C seropositivity
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent